ASC 4250-01 SUPER TURBOVAC 90,90 DEGRE

Description of Event or Problem

IT WAS REPORTED A PIECE BROKE OFF THE WAND AND WAS RETRIEVED BY THE PHYSICIAN WITH A GRASPER.

Additional Manufacturer Narrative

SUPPLEMENTAL DOCUMENTATION CHANGED/ADDITIONAL INFORMATION ADDED. H5 INVESTIGATION CONCLUSION - ZCD00006/UNCONFIRMED DEFECT. H10 INVESTIGATION REPORT READS AS FOLLOWS: 08/02/2021 10:03:04 CST (JWILDER), INVESTIGATION: "ONE DEVICE WAS RECEIVED FROM (B)(6) CENTER ON (B)(6) 2021. THE DEVICE WAS CONFIRMED TO BE AN ARTHROCARE SUPER TURBOVAC90, 90 DEGREE, SUCTION ARTHROWAND®, (WHITE/GREY) 3.5MM, PART # ASC 4250- 01. ALTHOUGH THE MEDLINE RENEWAL PACKAGES WAS NOT RETURNED WITH THE DEVICE, THE LOT NUMBER REPORTED ON THE COMPLAINT FORM WAS 432135. UPON INSPECTION OF THE DEVICE HANDLE, IT WAS OBSERVED THAT THE DEVICE HAD TWO MEDLINE RENEWAL REPROCESSING MARKS. DURING THE INVESTIGATION, THE DEVICE WAS INSPECTED FOR NONCONFORMITIES PER INTERNAL PROCEDURE. UPON INSPECTION, THE DEVICE WAS NOTED TO HAVE DEBRIS, INDICATING IT HAD BEEN CLINICALLY USED. UPON INSPECTION, NO ISSUES OR DAMAGE TO THE DEVICE WAS OBSERVED. THE REPORTED ISSUE WAS NOT CONFIRMED. ROOT CAUSE: THE EXACT ROOT CAUSE OF THE DEVICE FAILURE COULD NOT BE DETERMINED. UPON INSPECTION OF THE RETURNED DEVICE, THE ABLATION WAND WAS OBSERVED TO BE INTACT AND FREE OF DAMAGE. CONCLUSIONS: UPON INSPECTION OF THE RECEIVED DEVICE, THE ABLATION WAND WAS OBSERVED TO BE INTACT AND THERE WAS NO DAMAGE OBSERVED. THE REPORTED ISSUE WAS NOT CONFIRMED."

Additional Manufacturer Narrative

IT WAS REPORTED A PIECE BROKE OFF THE WAND AND WAS RETRIEVED BY THE PHYSICIAN WITH A GRASPER. EMAIL RECEIVED BY FACILITY REPRESENTATIVE, (B)(6), WHO PROVIDED ADDITIONAL INFORMATION IN REGARDS TO THIS INCIDENT. REPORTER STATES, "INCIDENT OCCURRED DURING A SHOULDER ARTHROSCOPY. PHYSICIAN WAS USING DEVICE AND A PIECE OF THE TIP BROKE OFF INTO THE SHOULDER SURGICAL SITE." REPORTER STATES, "DR. WAS ABLE TO RETRIEVE AND REMOVE BROKEN PIECE FROM PATIENTS SHOULDER." IT WAS REPORTED PHYSICIAN USED A GRASPER TO RETRIEVE THE BROKEN PIECE. REPORTER STATES, NO SERIOUS INJURY OR FOLLOW-UP CARE IS NEEDED. PATIENT IS REPORTED AS HAVING "NO ISSUES." SAMPLE HAS BEEN RETURNED FOR EVALUATION AND INVESTIGATIONAL REPORT IS PENDING. DUE TO THE REPORTED INCIDENT, MEDICAL INTERVENTION AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED A PIECE BROKE OFF THE WAND AND WAS RETRIEVED BY THE PHYSICIAN WITH A GRASPER.